This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.

Detailed Description

This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be studied:

People with ALS People diagnosed with early ALS (possible, probable, probable- laboratory supported or definite ALS according to El Escorial criteria)

Other Neurological Diseases People with a diagnosis of a disease that mimics ALS

Healthy Controls Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.

Condition ICMJE

Amyotrophic Lateral Sclerosis

Motor Neuron Disease

Charcot-Marie-Tooth Disease

Multiple Sclerosis

Intervention ICMJE

Device: Electrical impedance myography (EIM)

In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed.

EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time.

Other Name: EIM1102 device

Study Group/Cohort (s)

People with ALS

People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria)

Intervention: Electrical Impedance Myography (EIM).

Intervention: Device: Electrical impedance myography (EIM)

Other Neurological Diseases

People with a diagnosis of a disease that mimics ALS

Intervention: Device: Electrical impedance myography (EIM)

Healthy Controls

Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.

Intervention: Device: Electrical impedance myography (EIM)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

120

Estimated Completion Date

October 2015

Estimated Primary Completion Date

October 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Early ALS Inclusion Criteria:

Sporadic or familial ALS (as defined by revised El Escorial criteria)

Onset of weakness or spasticity due to ALS ≤ 36 months prior to the Screening/Baseline Visit.

Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age

Early ALS Exclusion Criteria:

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.

ALS Disease Mimics Inclusion Criteria:

- Diagnosis of one of the following:

a. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii. Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness involving more than one extremity or more than a single myotome if restricted to one extremity.

The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.

Healthy Volunteer Inclusion Criteria:

- Absence of a known neurological disorder.

Healthy Volunteer Exclusion Criteria:

History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative disease.

Presence of positive family history of ALS.

The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.

*Please note that this is not a complete listing on all eligibility criteria.*